Sr. R&D Engineer (Tech Lead)

Company: Access Vascular
Location: Billerica
Posted on: August 3, 2022

Job Description:

Are you a senior engineer that has taken medical devices all the way through each phase of development under design control? Do you aspire to grow in to a managerial position? Do you have experience in a start up environment? If so we want to talk to you!" This Sr. Engineer position will provide technical leadership, driving the design and execution of new products being developed at Access Vascular, within the multidisciplinary R team. The position requires extensive knowledge and experience with the design control process of a medical device. The candidate will have defined customer requirements, design inputs and outputs and successfully completed verification and validation activities. Additionally, this role requires working knowledge of sterilization validation, biocompatibility testing and an understanding of design considerations for implantable medical devices. An understanding of chemistry and product development experience are essential, extrusion and manufacturing knowledge is a plus. The primary responsibilities for this role will be oversite of the technical portion of the project including scheduling/planning of R work while interfacing and collaborating with all other functional groups in the organization. This role will define the technical direction for the project and ensure completion of deliverables to the larger project schedule. This individual will work under minimal supervision. Excellent communication skills are needed to understand and manage project/product needs and update status to internal and external customers. This individual will also provide direction and mentorship to technical team members. DUTIES AND RESPONSIBILITIES This individual will be responsible for all aspects of the technical team, its deliverables and providing mentorship and leadership to the project team members. This includes defining the long and short-term R deliverables of the project as well as identifying resources required to execute the project milestones. This individual will have the ability to design, develop/fabricate, and test prototype devices, demonstrating intensive and diversified knowledge of engineering principles and practices in broad areas of assignments. Must make data-based decisions on engineering problems and suggest future iterations/testing. Must keep clear record of past testing, results and learnings as technical risks and challenges are addressed and solved. This individual will contribute to assembling, publishing, and updating a schedule of all R project deliverables while understanding of how that fits into the larger project schedule. Expected to partner with the Sales and Marketing, Operations, Quality and Regulatory Affairs departments during all phases of product development. A strong understanding and a working knowledge of 21 CFR 820 and ISO 13485. Experience with other worldwide regulatory agencies a plus. This individual will have working knowledge of ISO 10993 and have completed Biocompatibility Risk Assessment activities previously. Excellent written communication skills. This individual will own the technical documents for the project and will be responsible for the assembly of the R deliverables for the DHF. Excellent oral communication skills. Effectively communicates and works cooperatively with others as part of a team. A basic understanding of chemistry. This individual may supervise engineering support/technicians and/or co-ops. This position will involve interacting with outside contractors and involved in transfer to manufacturing. This position may require travel up to 5%. QUALIFICATIONS A minimum of a Bachelor's degree in Engineering discipline is required; Master's degree a plus 8+ years of experience in a medical device company, with demonstrated experience in design control. Embody the AVI Guiding Principles to each job Qualifications With a MS, 6+ years of experience in a medical device company, with demonstrated experience in design control. CAD (SolidWorks) proficiency is required. Experience with rapid prototyping technologies is a plus Ability to respond to changing priorities and to multi-task, in a dynamic environment. In-depth understanding of quality systems and design control. Working knowledge of a cleanroom environment is required. Design proficiency as it relates to medical devices is required. Excellent leadership, time management, organizational, and prioritization skills to successfully complete a wide variety of complex job duties and responsibilities in a timely manner. Work in a team environment is required. Previous work in a start-up environment is a preferred. Hands-on work/understanding of extrusion theory and practice is a plus. While performing the duties of this job, the employee is regularly required to stand, sit, walk, talk, hear and reach with hands and arms. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. A willingness to work in a laboratory environment is required. Mechanical skills, including the ability to manipulate common hand tools, is required. Ability to read, write and communicate in English. Conditions of Employment: Candidates will be required to show proof they are vaccinated against COVID-19 prior to commencing employment. For purposes of this requirement, "vaccinated" shall have the then-current meaning ascribed by the US Center for Disease Control and Prevention (CDC). Exemptions from this requirement as a reasonable accommodation will be considered on a case-by-case basis in accordance with applicable law. Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status. About Access Vascular Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and are capable of long-term thrombus resistance and infection protection.

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